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DC Field | Value | Language |
---|---|---|
dc.contributor.author | Palmer J. | en |
dc.contributor.author | Lum C. | en |
dc.contributor.author | Behren A. | en |
dc.contributor.author | Tebbutt N.C. | en |
dc.contributor.author | Cebon J. | en |
dc.contributor.author | Carlino M.S. | en |
dc.contributor.author | Klein O. | en |
dc.contributor.author | Kee D. | en |
dc.contributor.author | Nagrial A. | en |
dc.contributor.author | Markman B. | en |
dc.contributor.author | Underhill C. | en |
dc.contributor.author | Michael M. | en |
dc.contributor.author | Jackett L. | en |
dc.date.accessioned | 2021-05-14T09:48:04Z | en |
dc.date.available | 2021-05-14T09:48:04Z | en |
dc.date.copyright | 2020 | en |
dc.date.created | 20201023 | en |
dc.date.issued | 2020-10-23 | en |
dc.identifier.citation | JAMA Oncology. 6 (9) (pp 1405-1409), 2020. Date of Publication: September 2020. | en |
dc.identifier.issn | 2374-2437 | en |
dc.identifier.uri | https://repository.monashhealth.org/monashhealthjspui/handle/1/29052 | en |
dc.description.abstract | Importance: Biliary tract cancers represent a rare group of malignant conditions with very limited treatment options. Patients with advanced disease have a poor outcome with current therapies. Objective(s): To evaluate the efficacy and safety of combination immunotherapy with nivolumab and ipilimumab in patients with advanced biliary tract cancers. Design, Setting, and Participant(s): The CA209-538 prospective multicenter phase 2 nonrandomized clinical trial included patients with advanced rare cancers including patients with biliary tract cancers. This subgroup analysis evaluated 39 patients from CA209-538 with biliary tract cancers who were enrolled from December 2017 to December 2019. Most of the patients (n = 33) had experienced disease progression after 1 or more lines of therapy and had tumor tissue available for biomarker research. Intervention(s): Patients received treatment with nivolumab at a dose of 3 mg/kg and ipilimumab at 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab 3 mg/kg every 2 weeks and continued for up to 96 weeks until disease progression or the development of unacceptable toxic events. Main Outcomes and Measures: The primary end point was disease control rate (complete remission, partial remission, or stable disease) as assessed by RECIST 1.1. Result(s): Among the 39 patients included in this subgroup analysis of a phase 2 clinical trial (20 men, 19 women; mean [range] age, 65 [37-81] years), the objective response rate was 23% (n = 9) with a disease control rate of 44% (n = 17); all responders had received prior chemotherapy, and none had a microsatellite unstable tumor. Responses were exclusively observed in patients with intrahepatic cholangiocarcinoma and gallbladder carcinoma. The median duration of response was not reached (range, 2.5 to =23 months). The median progression-free survival was 2.9 months (95% CI, 2.2-4.6 months), and overall survival was 5.7 months (95% CI, 2.7-11.9 months). Immune-related toxic events were reported in 49% of patients (n = 19), with 15% (n = 6) experiencing grade 3 or 4 events. Conclusions and Relevance: This subgroup analysis of a phase 2 clinical trial found that combination immunotherapy with nivolumab and ipilimumab was associated with substantial positive outcomes patients with advanced biliary tract cancers. This treatment compares favorably to single-agent anti-programmed cell death protein 1 (anti-PD-1) therapy and warrants further investigation. Ongoing translational research is focused on identifying biomarkers that can predict treatment response. Trial Registration: ClinicalTrials.gov Identifier: NCT02923934.Copyright © 2020 American Medical Association. All rights reserved. | en |
dc.language | en | en |
dc.language | English | en |
dc.publisher | American Medical Association (E-mail: shirley.martin@ama-assn.org) | en |
dc.relation.ispartof | JAMA Oncology | - |
dc.subject | cancer patient | en |
dc.subject | *nivolumab/iv [Intravenous Drug Administration] | en |
dc.subject | *nivolumab/pd [Pharmacology] | en |
dc.subject | *nivolumab/pv [Special Situation for Pharmacovigilance] | en |
dc.subject | triacylglycerol lipase/ec [Endogenous Compound] | en |
dc.subject | abdominal pain/si [Side Effect] | en |
dc.subject | abnormally high substrate concentration in blood/si [Side Effect] | en |
dc.subject | adrenal insufficiency/si [Side Effect] | en |
dc.subject | adult | en |
dc.subject | advanced cancer/dt [Drug Therapy] | en |
dc.subject | aged | en |
dc.subject | anemia/si [Side Effect] | en |
dc.subject | antineoplastic activity | en |
dc.subject | article | en |
dc.subject | *bile duct carcinoma/dt [Drug Therapy] | en |
dc.subject | *cancer combination chemotherapy | en |
dc.subject | cancer control | en |
dc.subject | cancer immunotherapy | en |
dc.subject | cancer regression | en |
dc.subject | cancer survival | en |
dc.subject | cancer tissue | en |
dc.subject | clinical article | en |
dc.subject | cohort analysis | en |
dc.subject | colitis/si [Side Effect] | en |
dc.subject | controlled study | en |
dc.subject | decreased appetite/si [Side Effect] | en |
dc.subject | diarrhea/si [Side Effect] | en |
dc.subject | drug efficacy | en |
dc.subject | drug eruption/si [Side Effect] | en |
dc.subject | drug fatality/si [Side Effect] | en |
dc.subject | drug fever/si [Side Effect] | en |
dc.subject | drug safety | en |
dc.subject | drug screening | en |
dc.subject | drug withdrawal | en |
dc.subject | endocrine disease/si [Side Effect] | en |
dc.subject | fatigue/si [Side Effect] | en |
dc.subject | female | en |
dc.subject | *gallbladder carcinoma/dt [Drug Therapy] | en |
dc.subject | hepatitis/si [Side Effect] | en |
dc.subject | human | en |
dc.subject | human tissue | en |
dc.subject | hyperthyroidism/si [Side Effect] | en |
dc.subject | hypertransaminasemia/si [Side Effect] | en |
dc.subject | hypophosphatemia/si [Side Effect] | en |
dc.subject | hypothyroidism/si [Side Effect] | en |
dc.subject | immunopathology/si [Side Effect] | en |
dc.subject | injection site reaction/si [Side Effect] | en |
dc.subject | kidney failure/si [Side Effect] | en |
dc.subject | lymphocytopenia/si [Side Effect] | en |
dc.subject | maintenance therapy | en |
dc.subject | male | en |
dc.subject | microsatellite instability | en |
dc.subject | monotherapy | en |
dc.subject | multicenter study | en |
dc.subject | nausea/si [Side Effect] | en |
dc.subject | outcome assessment | en |
dc.subject | overall survival | en |
dc.subject | phase 2 clinical trial | en |
dc.subject | pneumonia/si [Side Effect] | en |
dc.subject | progression free survival | en |
dc.subject | prospective study | en |
dc.subject | pruritus/si [Side Effect] | en |
dc.subject | response evaluation criteria in solid tumors | en |
dc.subject | treatment duration | en |
dc.subject | treatment response | en |
dc.subject | triacylglycerol lipase blood level | en |
dc.subject | very elderly | en |
dc.subject | *ipilimumab/ae [Adverse Drug Reaction] | en |
dc.subject | *ipilimumab/ct [Clinical Trial] | en |
dc.subject | *ipilimumab/cb [Drug Combination] | en |
dc.subject | *ipilimumab/dt [Drug Therapy] | en |
dc.subject | *ipilimumab/iv [Intravenous Drug Administration] | en |
dc.subject | *ipilimumab/pd [Pharmacology] | en |
dc.subject | *ipilimumab/pv [Special Situation for Pharmacovigilance] | en |
dc.subject | *nivolumab/ae [Adverse Drug Reaction] | en |
dc.subject | *nivolumab/ct [Clinical Trial] | en |
dc.subject | *nivolumab/dt [Drug Therapy] | en |
dc.title | Evaluation of Combination Nivolumab and Ipilimumab Immunotherapy in Patients with Advanced Biliary Tract Cancers: Subgroup Analysis of a Phase 2 Nonrandomized Clinical Trial. | en |
dc.type | Article | en |
dc.type.studyortrial | Observational study (cohort, case-control, cross sectional or survey) | - |
dc.identifier.doi | http://monash.idm.oclc.org/login?url=http://acs.hcn.com.au/?acc=36265&url=http://dx.doi.org/10.1001/jamaoncol.2020.2814 | - |
dc.publisher.place | United States | en |
dc.identifier.pubmedid | 32729929 [http://www.ncbi.nlm.nih.gov/pubmed/?term=32729929] | en |
dc.identifier.source | 632531800 | en |
dc.identifier.institution | (Klein, Kee, Tebbutt, Cebon) Department of Medical Oncology, Austin Health, Melbourne, Australia (Klein, Behren, Palmer, Cebon) Olivia Newton-John Cancer Research Institute, Melbourne, Australia (Kee, Michael) Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia (Nagrial, Carlino) Blacktown Hospital and the University of Sydney, Sydney, Australia (Markman, Lum) Department of Medical Oncology, Monash Health, Melbourne, Australia (Markman) Monash University, Melbourne, Australia (Underhill) Albury-Wodonga Regional Cancer Centre, Albury-Wodonga, Australia (Jackett) Department of Anatomical Pathology, Austin Health, Melbourne, Australia (Behren, Palmer, Cebon) School of Cancer Medicine, La Trobe University, Australia (Tebbutt) Department of Surgery, University of Melbourne, Melbourne, Australia | en |
dc.description.address | O. Klein, Olivia Newton-John Cancer Centre, Austin Hospital, 145 Studley Rd, Heidelberg, VIC 3084, Australia. E-mail: oliver.klein@onjcri.org.au | en |
dc.subject.keyword | cancer control | en |
dc.subject.keyword | cancer immunotherapy | en |
dc.subject.keyword | cancer patient | en |
dc.subject.keyword | cancer regression | en |
dc.subject.keyword | cancer survival | en |
dc.subject.keyword | cancer tissue | en |
dc.subject.keyword | clinical article | en |
dc.subject.keyword | cohort analysis | en |
dc.subject.keyword | colitis / side effect | en |
dc.subject.keyword | controlled study | en |
dc.subject.keyword | decreased appetite / side effect | en |
dc.subject.keyword | diarrhea / side effect | en |
dc.subject.keyword | drug efficacy | en |
dc.subject.keyword | drug eruption / side effect | en |
dc.subject.keyword | drug fatality / side effect | en |
dc.subject.keyword | drug fever / side effect | en |
dc.subject.keyword | drug safety | en |
dc.subject.keyword | drug screening | en |
dc.subject.keyword | drug withdrawal | en |
dc.subject.keyword | endocrine disease / side effect | en |
dc.subject.keyword | fatigue / side effect | en |
dc.subject.keyword | female | en |
dc.subject.keyword | *gallbladder carcinoma / *drug therapy | en |
dc.subject.keyword | hepatitis / side effect | en |
dc.subject.keyword | human | en |
dc.subject.keyword | human tissue | en |
dc.subject.keyword | hyperthyroidism / side effect | en |
dc.subject.keyword | hypertransaminasemia / side effect | en |
dc.subject.keyword | hypophosphatemia / side effect | en |
dc.subject.keyword | hypothyroidism / side effect | en |
dc.subject.keyword | immunopathology / side effect | en |
dc.subject.keyword | injection site reaction / side effect | en |
dc.subject.keyword | kidney failure / side effect | en |
dc.subject.keyword | lymphocytopenia / side effect | en |
dc.subject.keyword | maintenance therapy | en |
dc.subject.keyword | male | en |
dc.subject.keyword | microsatellite instability | en |
dc.subject.keyword | monotherapy | en |
dc.subject.keyword | multicenter study | en |
dc.subject.keyword | nausea / side effect | en |
dc.subject.keyword | outcome assessment | en |
dc.subject.keyword | overall survival | en |
dc.subject.keyword | phase 2 clinical trial | en |
dc.subject.keyword | pneumonia / side effect | en |
dc.subject.keyword | progression free survival | en |
dc.subject.keyword | pruritus / side effect | en |
dc.subject.keyword | response evaluation criteria in solid tumors | en |
dc.subject.keyword | treatment duration | en |
dc.subject.keyword | treatment response | en |
dc.subject.keyword | triacylglycerol lipase blood level | en |
dc.subject.keyword | very elderly | en |
dc.subject.keyword | adrenal insufficiency / side effect | en |
dc.subject.keyword | abnormally high substrate concentration in blood / side effect | en |
dc.subject.keyword | abdominal pain / side effect | en |
dc.subject.keyword | prospective study | en |
dc.subject.keyword | adult | en |
dc.subject.keyword | advanced cancer / drug therapy | en |
dc.subject.keyword | aged | en |
dc.subject.keyword | anemia / side effect | en |
dc.subject.keyword | antineoplastic activity | en |
dc.subject.keyword | Article | en |
dc.subject.keyword | *bile duct carcinoma / *drug therapy | en |
dc.subject.keyword | *cancer combination chemotherapy | en |
dc.relation.libraryurl | LibKey Link | en |
dc.description.publicationstatus | Embase | en |
dc.rights.statement | Copyright 2020 Elsevier B.V., All rights reserved. | en |
dc.identifier.authoremail | Klein O.; oliver.klein@onjcri.org.au | en |
item.openairetype | Article | - |
item.cerifentitytype | Publications | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.grantfulltext | none | - |
item.fulltext | No Fulltext | - |
Appears in Collections: | Articles |
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